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Biowaivers: Practical and Regulatory Approaches - Online Academy

4 week online course beginning on Monday 5th November 2018

Online Academy

Syllabus
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Biowaivers represent a useful alternative to performing in-vivo studies for generic drugs.

This course will help improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks, using case studies and practical guidance. By examining the requirements for BCS-based, Strength and IVIVC biowaivers, you will have the confidence and skills to implement a strategic approach for new product registrations.

  • Introduction to biopharmacy
  • Understand the legal basis for biowaivers
  • Investigate BCS biowaivers
  • Comprehend Strength biowaivers
  • Understand dissolution data to be submitted
  • Consider applications of IVIVC biowaivers
  • Learn about and compare US-FDA and EMA regulations

This course is designed for professionals involved in the development/ registration of generic products. Attendees may work in the following areas:

  • Regulatory Affairs
  • Pharmaceutical Development
  • Analytical Development
  • IVIVC
  • R&D for generics

Jean-Michel Cardot is a professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. His laboratory research fields are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and IVIVC.

To find out more about Jean-Michel Cardot, you can watch 'Meet our Trainers' video featuring Jean-Michel on our YouTube channel by clicking here.

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores how to optimise IVIVC using your dissolution data.

Topics covered:

  • Basis of IVIVC
  • Why IVIVC and dissolution are important
  • Use in development: interest and limitations
  • Optimisation of formulation based on IVIVC
  • Conclusions and Q&A session

Testimonials about the course leader:

The trainer was very experienced with many examples and encouraged time for questions.


Regulatory Affairs International Project Manager, Medac GmbH

The trainer was very knowledgeable and had good presentation skills.

Director, Northumbria Pharma


The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.

Regulatory Affairs Development Manager, Regivet BV


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